BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2021/2282 lays down a support framework and procedures for cooperation between Member States on health technologies at Union level and establishes the Member State Coordination Group on Health Technology Assessment (‘the Coordination Group’). 

(2) Pursuant to Article 16(1) of Regulation (EU) 2021/2282, the Coordination Group is to carry out joint scientific consultations in order to exchange information with health technology developers on their development plans for a medicinal product for human use (‘medicinal product’). The aim of such consultations is to facilitate the process of preparing joint clinical assessments for medicinal products, as they will allow health technology developers to obtain guidance from the Coordination Group on the information, data, analyses and other evidence that are likely to be required from clinical studies for the joint clinical assessment of those medicinal products. 

(3) In order to ensure sufficient predictability for health technology developers as to their opportunity to engage in joint scientific consultations on medicinal products with the Coordination Group, it is necessary to specify the deadline for the Coordination Group to set the dates of request periods for joint scientific consultation on medicinal products for the subsequent year, as well as the minimum number of such request periods per year. Under Article 6(2), point (b), of Regulation (EU) 2021/2282, the Coordination Group is to set out in its annual work programme the planned number of joint scientific consultations. To allow the health technology developers sufficient time to plan and prepare for joint scientific consultations on medicinal products, the Coordination Group should set the request periods for those consultations at the latest by the day on which it adopts its annual work programme, that is, by 30 November each year. 

(4) Under Article 30(1) of Regulation (EU) 2021/2282, the Commission is to set up and maintain an IT platform consisting of, inter alia, a secure system for the exchange of information between the Coordination Group and its subgroups with health technology developers and experts participating in the joint work (‘the HTA IT platform’). The health technology developers should therefore submit the requests for joint scientific consultation, the dossier of information, data, analyses and other evidence for joint scientific consultation on medicinal products including the list of questions (‘the briefing package’) and any further data through the HTA IT platform. Those requests and dossiers should be presented using the templates set out by the Coordination Group pursuant to Article 21, points (a) and (b), of Regulation (EU) 2021/2282. 

(5) Upon request from a health technology developer, joint scientific consultations on medicinal products may take place in parallel with the scientific advice on medicinal products by the European Medicines Agency pursuant to Article 57(1), point (n), of Regulation (EC) No 726/2004 of the European Parliament and of the Council2 (‘scientific advice’). In order for the subgroup on joint scientific consultations of the Coordination Group (‘JSC Subgroup’) to be able to identify the requests for joint scientific consultation to be conducted in parallel with the scientific advice, the health technology developer should indicate in the request for joint scientific consultation whether, in parallel, it is requesting scientific advice from the European Medicines Agency. 

(6) Pursuant to Article 28, point (h), of Regulation (EU) 2021/2282, the Commission acting as secretariat of the Coordination Group (‘HTA secretariat’) is to facilitate the cooperation with the European Medicines Agency. The exchange of information with the European Medicines Agency relevant to joint scientific consultations on medicinal products should therefore take place through the HTA secretariat. 

(7) The HTA secretariat should inform the European Medicines Agency of granted requests for joint scientific consultation on medicinal products to be conducted in parallel with the scientific advice. Where joint scientific consultations on medicinal products are conducted in parallel with the scientific advice, the HTA secretariat and the European Medicines Agency should exchange the appropriate information to ensure that the parallel consultations have synchronised timing. 

(8) Where pursuant to Article 17(4) of Regulation (EU) 2021/2282, the Coordination Group, via the HTA secretariat, informs the health technology developer that it will engage in the joint scientific consultation on medicinal products, it should also inform the health technology developer of the timetable for the joint scientific consultation, including the deadline to submit the briefing package. To ensure that joint scientific consultations on medicinal products that are conducted in parallel with the scientific advice have synchronised timing, the timetable should be synchronised with the scientific advice process. 

(9) To ensure the effective involvement of patients, clinical experts and other relevant experts (‘individual experts’) in joint scientific consultation on medicinal products, the HTA secretariat should start their identification as early as possible. Therefore, at the same time as the JSC Subgroup selects medicinal products that are to be subject to joint scientific consultation, the JSC Subgroup should also specify, for each joint scientific consultation, the disease, the therapeutic area concerned and other specific expertise, based on which the HTA secretariat is to identify individual experts to be consulted during that joint scientific consultation. To identify the individual experts, the HTA secretariat should consult the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282, the European reference networks for rare and complex diseases and other relevant sources, agencies and organisations. In making the final selection, the JSC Subgroup should give priority to individual experts who have expertise, across several Member States, in the disease or therapeutic area of the joint scientific consultation. 

(10) The JSC Subgroup, via the HTA secretariat, should share with the selected individual experts the briefing package and should give them the opportunity to provide input on the joint scientific consultation. The HTA secretariat should invite the selected individual experts to the meeting for an exchange of views with the health technology developer referred to in Article 18(7) and (8) of Regulation (EU) 2021/2282. At any time during the joint scientific consultation, the JSC Subgroup should have the possibility to consult stakeholder organisations. In particular, such consultation should entail a more general input on the disease and therapeutic area from patient organisations, healthcare professional organisations or clinical and learned societies and should be conducted via the members of the stakeholder network. Such consultation must not disclose the actual medicinal product subject to the joint scientific consultation. 

(11) In order to ensure that individual experts take part in joint scientific consultation in an independent and transparent manner, free from conflict of interest, they should only be selected and involved in joint scientific consultations after the Commission has assessed their declared interests, in accordance with Article 5 of Regulation (EU) 2021/2282 and with Article 4 of Commission Implementing Regulation (EU) 2024/2745. 

(12) To reduce administrative burden and avoid duplication, where joint scientific consultations on medicinal products are conducted in parallel with the scientific advice, the health technology developer should submit the same documentation to the HTA secretariat and to the European Medicines Agency. For this purpose, before establishing the template of the briefing package pursuant to Article 21, point (b), of Regulation (EU) 2021/2282 to be used where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the Coordination Group should consult and reach agreement with the European Medicines Agency on the template. 

(13) To ensure that joint scientific consultations on medicinal products that are conducted in parallel with the scientific advice have synchronised timing, the health technology developer should submit the relevant documentation for joint scientific consultation and scientific advice at the same time to the HTA secretariat and the European Medicines Agency. Moreover, the JSC Subgroup or the Coordination Group and the European Medicines Agency should, within the set timetable, approve, adopt and submit to the health technology developer the lists of issues, the joint scientific consultation outcome document and the advice letter. 

(14) With the view of facilitating the discussion with the health technology developer and consultation of individual experts at the meeting referred to in Article 18(7) of Regulation (EU) 2021/2282, the JSC Subgroup, via the HTA secretariat, should share with the health technology developer the list of issues indicating the topics to be addressed at the meeting and where relevant the specific questions to be addressed only in writing before that meeting (‘the list of issues’). The JSC Subgroup should give the health technology developer the opportunity to respond to the list of issues in writing in due time before the meeting. 

(15) Where joint scientific consultations on medicinal products are conducted in parallel with the scientific advice, the HTA secretariat and the European Medicines Agency should exchange the respective lists of issues. The JSC Subgroup and the European Medicines Agency should discuss the lists of issues with the health technology developer in one single meeting. It should be specified which parties are to be invited to this joint meeting. The meeting should be held virtually and be co-chaired by the assessor or co-assessor for joint scientific consultation appointed pursuant to Article 18(3) of Regulation (EU) 2021/2282 (‘the assessor and co-assessor’) and one of the coordinators for scientific advice. 

(16) Where the health technology developer amends the development plan of a medicinal product after the submission of the briefing package, it is necessary to set the deadline by which the health technology developer is to submit the relevant updates to the JSC Subgroup so that those updates can be considered in the joint scientific consultation outcome document. 

(17) To ensure transparency, traceability and professional secrecy, the documentation related to joint scientific consultations on medicinal products should be sent in a digital format and should be exchanged with and between the Coordination Group, the JSC Subgroup, the HTA Secretariat, the health technology developer, and individual experts during joint scientific consultations on medicinal products through the HTA IT platform. 

(18) In accordance with Article 5(1), point (a), of Regulation (EU) 2018/1725 of the European Parliament and of the Council, it is necessary to lay down the rules for processing of personal data for the purposes of conducting joint scientific consultations on medicinal products. In particular, it is necessary to specify the personal data that may be processed, namely certain personal data relating to the individual experts involved in joint scientific consultations on medicinal products and certain personal data relating to the representatives appointed to the Coordination Group and the JSC Subgroup, the representatives of health technology developers and the representatives of the members of the stakeholder network. Where joint scientific consultations on medicinal products are conducted in parallel with the scientific advice, the Commission should receive from the European Medicines Agency the list of participants involved in the scientific advice that are invited to the meeting with the health technology developer. 

(19) The Commission should be considered the controller of the processing of personal data within the meaning of Article 3, point (8), of Regulation (EU) 2018/1725. Any processing of personal data by the European Medicines Agency and by the members of the Coordination Group and the JSC Subgroup and their representatives outside of the HTA IT platform is to take place in accordance with, respectively, Regulation (EU) 2018/1725 and Regulation (EU) 2016/679 of the European Parliament and of the Council. 

(20) To ensure the possibility to verify whether joint scientific consultations on medicinal products were conducted in an independent and impartial manner, for example, in the event of complaints or litigation, as well as to ensure the relevant in-depth specialised expertise in joint scientific consultation and to verify compliance with the requirement set out in Article 8(4) of Regulation (EU) 2021/2282 that the assessor and co-assessor for joint clinical assessment are to be different from the assessor and co-assessor for joint scientific consultation, it is necessary to provide for appropriate retention periods with regard to personal data and for their review at regular intervals. 

(21) The identity of patients may reveal the patient’s health status in relation to the subject matter of the joint scientific consultation and should therefore be considered a special category of personal data under Article 10 of Regulation (EU) 2018/1725. Such data should only be processed where the criteria set out in Article 10(2), point (i), of that Regulation are met. It is necessary to provide for suitable and specific measures to safeguard the rights and freedoms of the patient. In particular, patients should not be obliged to disclose their identity to the health technology developer. Under Article 5(6) of Regulation (EU) 2021/2282, the representatives appointed to the Coordination Group and the JSC Subgroup, as well as individual experts involved in joint scientific consultations, are subject to a requirement of professional secrecy, even after their duties have ceased. In order to ensure protection of personal data and of confidential information, it is necessary to provide that only individual experts who have signed confidentiality agreements may be involved in joint scientific consultations on medicinal products. 

(22) The Coordination Group was consulted on these procedural rules on 10 June 2024 in accordance with Article 20(1) of Regulation (EU) 2021/2282. 

(23) Regulation (EU) 2021/2282 starts to apply on 12 January 2025 and this Regulation should apply from the same date. 

(24) The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered an opinion on 6 November 2024. 

(25) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Health Technology Assessment,